Diuretics and Angiotensin-Receptor Blocker Agents in Patients With Stage I Hypertension

NCT00971165 | Completed Phase 3 DMC

• 1 other identifier: GPPG08621-2
• Study Type: interventional
• Target: 655
• Locations: 1 country
• Sites: 2

Brief Summary

High blood pressure is the major risk factor for Cardiovascular disease (CVD). The prevalence of hypertension in Brazil was established in population-based studies conducted in different cities and States, varying from 22.3 to 44% of adults. The benefit of drug treatment of hypertension to prevent major cardiovascular events was consistently demonstrated in a large series of clinical trials controlled by placebo. Diuretics are at least as efficacious as other blood pressure-lowering drugs, are well tolerated, have longer duration of action and the advantage of very low cost to be used in a population intervention. Chlorthalidone is the more efficacious agent. Its main limitation is to induce hypokalemia in a proportion of patients, an adverse effect that can be antagonized by a potassium-sparing diuretic, as amiloride. A study comparing diuretic with an ARB agent is therefore recommendable in Brazil, in order to support the decisions of the Health Secretary in regard to blood pressure agents supply for the Brazilian population. Such a study was demanded and funded by the Health and Technology Ministries in Brazil.

Conditions

Hypertension; Cardiovascular Disease

Keywords

Hypertension; Chlorthalidone; Amiloride; Losartan; treatment

Outcome Measures

Primary Outcomes (3)

• Blood pressure variation and proportion of use of add-on drugs

  18 months

• Adverse events

  18 months

• Development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG.

  18 monyhs

Secondary Outcomes (1)

• fatal or major cardiovascular events: myocardial infarction, stroke, coronary interventions, heart failure, duplication of creatinine

  18 months

Study Arms (2)

Chlorthalidone plus amiloride

ACTIVE COMPARATOR

Oral Chlorthalidone plus amiloride up to 25 e 5 mg daily for 18 months

Drug: Chlorthalidone plus amiloride

losartan

EXPERIMENTAL

Oral losartan up to 100 mg daily, once a day, for 18 month

Drug: losartan

Interventions

losartan DRUG

Oral losartan up to 100 mg daily fo 18 months

losartan

Chlorthalidone plus amiloride DRUG

Oral Chlorthalidone plus amiloride up to 25 e 5 mg daily, once a day for 18 months

Also known as: diuretics

Chlorthalidone plus amiloride

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients older than 40 years of age with stage I hypertension

You may not qualify if:

• low life expectancy
• other indications for the use of diuretics, such as cardiovascular disease
• intolerance to the study drugs
• pregnancy

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Financiadora de Estudos e Projetos: collaborator

Study Sites (2)

Hospital de Clínicas de Porto Alegre, UFRGS

Porto Alegre, Rio Grande do Sul, 90035 903, Brazil

Location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Related Publications (3)

• Fuchs FD, Fuchs SC, Moreira LB, Gus M, Nobrega AC, Poli-de-Figueiredo CE, Mion D, Bortolotto L, Consolim-Colombo F, Nobre F, Coelho EB, Vilela-Martin JF, Moreno H Jr, Cesarino EJ, Franco R, Brandao AA, de Sousa MR, Ribeiro AL, Jardim PC, Afiune Neto A, Scala LC, Mota M, Chaves H, Alves JG, Sobral Filho DC, Pereira e Silva R, Figueiredo Neto JA, Irigoyen MC, Castro I, Steffens AA, Schlatter R, de Mello RB, Mosele F, Ghizzoni F, Berwanger O. A comparison between diuretics and angiotensin-receptor blocker agents in patients with stage I hypertension (PREVER-treatment trial): study protocol for a randomized double-blind controlled trial. Trials. 2011 Feb 24;12:53. doi: 10.1186/1745-6215-12-53.

  PMID: 21349192 BACKGROUND

• Fuchs FD, Scala LCN, Vilela-Martin JF, Whelton PK, Poli-de-Figueiredo CE, Pereira E Silva R, Gus M, Bortolotto LA, Consolim-Colombo FM, Schlatter RP, Cesarino JE, Castro I, Figueiredo Neto JA, Chaves H, Steffens AA, Alves JG, Brandao AA, de Sousa MR, Jardim PC, Moreira LB, Franco RS, Gomes MM, Afiune Neto A, Fuchs FC, Sobral Filho DC, Nobrega AC, Nobre F, Berwanger O, Fuchs SC. Effectiveness of chlorthalidone/amiloride versus losartan in patients with stage I hypertension and diabetes mellitus: results from the PREVER-treatment randomized controlled trial. Acta Diabetol. 2021 Feb;58(2):215-220. doi: 10.1007/s00592-020-01611-8. Epub 2020 Oct 13.

  PMID: 33047257 DERIVED

• Fuchs FD, Scala LC, Vilela-Martin JF, de Mello RB, Mosele F, Whelton PK, Poli-de-Figueiredo CE, de Alencastro PR, E Silva RP, Gus M, Bortolotto LA, Schlatter R, Cesarino EJ, Castro I, Neto JA, Chaves H, Steffens AA, Alves JG, Brandao AA, de Sousa MR, Jardim PC, Moreira LB, Franco RS, Gomes MM, Neto AA, Fuchs FC, Filho DC, Nobrega AC, Nobre F, Berwanger O, Fuchs SC. Effectiveness of chlorthalidone/amiloride versus losartan in patients with stage I hypertension: results from the PREVER-treatment randomized trial. J Hypertens. 2016 Apr;34(4):798-806. doi: 10.1097/HJH.0000000000000837.

  PMID: 26938814 DERIVED

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Interventions

Losartan; Chlorthalidone; Amiloride; Diuretics

Condition Hierarchy (Ancestors)

Vascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Benzenesulfonamides; Sulfonamides; Amides; Benzophenones; Phthalimides; Imides; Ketones; Sulfones; Sulfur Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrazines; Natriuretic Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Flávio D Fuchs, MD, PhD

  Hospital de Clínicas de Porto Alegre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: September 2, 2009
• First Posted: September 3, 2009
• Study Start: July 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: February 12, 2015

Record last verified: 2015-02

Locations

BR (2)